Quality & Regulatory Affairs Manager - £45K (£50K OTE)

Job Ref:	6392
Position:	Quality & Regulatory Affairs Manager
Category:	Clinical - Quality Assurance
Basic:	£45000
OTE:	£50000
Location:	London
Description:	A highly innovative medical device manufacturer is expanding its team based in London and is now keen to recruit a Quality and Regulatory Affairs Manager.  The company is a world leader in surgical robotics and associated software that are used in orthopaedic surgery.  The products are in clinical use in the UK and have undergone successful clinical trials.  The company is implementing quality management systems conforming to the requirements of ISO 13485, the medical device directive and FDA CFR part 820 covering medical devices.  The company is also preparing regulatory approvals for the US market.  The QA/Regulatory Affairs Manager will (with guidance from the senior management team) implement and maintain the quality management system, develop and execute strategies for approval to introduce the company's products to the global market.  You will provide expert knowledge and advice on quality regulatory requirements, prepare regulatory submissions and negotiate approval with various governing bodies and support all post-marketing activity.  The successful candidate will be a life science graduate with previous experience and knowledge of ISO 13485 and CFR Part 820; previous experience with medical devices is highly desirable and excellent written and communication skills will be essential.  This is a very exciting time to join a rapidly expanding company which has a novel and highly innovative product.  To discuss the role in greater detail contact us soon.
Consultant:	Scott Peacock
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